MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 6 of 7.Reference mfr.Report: 1627487-2018-07235, reference mfr.Report: 1627487-2018-07236, reference mfr.Report: 1627487-2018-07237, reference mfr.Report: 1627487-2018-07238, reference mfr.Report: 1627487-2018-07984, reference mfr.Report: 3006705815-2018-02034.Follow up information identified the patient experienced later issues with the incision site of the extensions re-opening, also.It is unknown if there was an issue at the ipg incision site, as well.As a result, the physician explanted the patient¿s extensions and the ipg.The patient¿s two extensions and ipg have been added as additional devices at this time.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: nirvana williams ; 9723098568
• MDR Report Key: 7865718
• MDR Text Key: 119862644
• Report Number: 1627487-2018-07985
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 6048191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other